Skip to content

NL – Novartis v. Sun / Skinny label injunction

12 Feb 2015

Novartis AG v. Sun Pharmaceutical Industries (Europe) B.V., Court of Appeal The Hague, The Netherlands, 27 January 2015, Case file number: Case file number: 200.1 50.713/01, with thanks to Rutger Kleemans, Freshfields, for sending in the judgment as well as a translation in English

The Court of Appeal of The Hague held Sun liable for indirect infringement of Novartis’ Swiss type claim on (in short) the use of zoledronic acid in a specific dosage range, form and regime for the treatment of osteoporosis, despite the fact that Sun was marketing its generic zoledronic acid under a skinny label on which the patented indication was carved out.

The Court held that there were various circumstances on the basis of which Sun at least should have known that its generic zoledronic acid was being used for the patented indication. The drug preference policy of a health insurer that made Sun its preferred supplier, forced pharmacies to give out Sun’s generic zoledronic acid – no matter what the indication was, and irrespective of whether or not the Novartis’ brand medicine was mentioned in the prescription –. Furthermore, the amount of sales were such that they could reasonably not be attributed to the non-patented indication alone.

Finally, in the eyes of the Court, Sun had not done enough to prevent that the generic zoledronic acid it delivered would be used for the patented indication. Sun had sent notifications to various parties informing them of the indication that was still patented, but these were, according to the Court, toothless, as Sun had failed to do everything in its power to ensure that its generic zoledronic acid would not be used for the treatment of osteoporosis.

Read the decision (in Dutch) here.
Read the decision (in English) here.

Head note: Geert Theuws, Hoyng Monegier